U.S. patent number 5,797,890 [Application Number 08/597,179] was granted by the patent office on 1998-08-25 for support devices for retaining a male urinary incontinence condom catheter onto a penis.
This patent grant is currently assigned to Goulter Medical Corporation. Invention is credited to Barbara Goulter, Victor H. Goulter.
United States Patent |
5,797,890 |
Goulter , et al. |
August 25, 1998 |
Support devices for retaining a male urinary incontinence condom
catheter onto a penis
Abstract
A support strap whose lower end is sewn to a hook-and-loop band
which encircles the sheath portion of a urine-collecting catheter
and the user's penis. Its upper end has male part snaps sewn to it,
which cooperate with female part snaps on the undergarment's
waistband. The strap and band prevent the external urinary catheter
from slipping off of the penis. The band has multiple indicating
marks on the loop side and one mark on the hook side, for accurate
repositioning of the band each time it is reapplied. A second
embodiment has a front section of a garment onto which is sewn a
grooved retainer ring, which encircles the penis. An applicator
ring is used to spread the rim of the condom catheter to facilitate
fitting the condom onto the penis and for fitting the rim into the
groove of the grooved retaining ring.
Inventors: |
Goulter; Victor H. (San
Francisco, CA), Goulter; Barbara (San Francisco, CA) |
Assignee: |
Goulter Medical Corporation
(Portland, OR)
|
Family
ID: |
24390431 |
Appl.
No.: |
08/597,179 |
Filed: |
February 6, 1996 |
Current U.S.
Class: |
604/351; 604/352;
604/353 |
Current CPC
Class: |
A61F
5/453 (20130101); A61F 5/4405 (20130101) |
Current International
Class: |
A61F
5/44 (20060101); A61F 5/453 (20060101); A61F
5/451 (20060101); A61F 005/44 () |
Field of
Search: |
;604/349,351,353,338,352
;128/760,842,844 ;4/144.1-144.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Weiss; John G.
Assistant Examiner: Cho; David J.
Attorney, Agent or Firm: Leary; James J. Titus; Carol D.
Claims
We claim:
1. A combination of a device for retaining an external urinary
catheter onto a penis of a wearer, said external urinary catheter
having a proximal end for encircling the penis of the wearer and an
undergarment having a waistband, said combination comprising:
an undergarment having a waistband to be worn about the wearer;
a band for encircling said proximal end of said external urinary
catheter;
a support strap having a first end and a second end, said first end
of said support strap being attached to said band;
and an adjustment means for adjusting the length of said support
strap comprising a plurality of attachment means positioned at
different positions along the length of said support strap, wherein
said plurality of attachment means are attached to said second end
of said support strap to said waistband of the undergarment having
an expandable pouch for supporting said external urinary
catheter.
2. The device of claim 1, wherein said band is made of an elastic
material, and wherein said band fastens about said proximal end of
said external urinary catheter with a hook and loop fastener.
3. The device of claim 1, wherein said band comprises a first end
portion and a second end portion and an adjustable fastening means
for connecting said first end portion to said second end portion in
an overlapping manner, the degree of overlapping between said first
end portion and said second end portion determining the tightness
of said band around said proximal end of said external urinary
catheter and the penis of the wearer, and wherein said band further
comprises a plurality of indicating marks for indicating the degree
of overlapping between said first end portion and said second end
portion and therefore the tightness of said band around said
proximal end of said external urinary catheter and the penis of the
wearer.
4. The combination of claim 1, wherein said plurality of attachment
means comprises removable attachment means selected from the group
consists of snaps, press studs, safety pins, buttons, hooks and
eyes, and hook and loop fasteners.
5. The combination of claim 1, wherein said band is made of an
elastic material and, wherein said band fastens about said proximal
end of said external urinary catheter with a hook and loop
fastener.
6. The combination of claim 1, wherein said band further comprises
an adjustable fastening means for fastening said band about said
proximal end of said external urinary catheter.
7. A combination of a device for retaining an external urinary
catheter onto a penis of a wearer, said external urinary catheter
having a proximal end for encircling the penis of the wearer and an
undergarment having a waistband, said combination comprising:
an undergarment having a waistband to be worn about the wearer;
a band for encircling said proximal end of said external urinary
catheter;
a support strap having a first end and a second end, said first end
of said support strap being attached to said band;
and an adjustment means for adjusting the length of said support
strap comprising a plurality of attachment means positioned at
different positions along the length of said support strap, wherein
said plurality of attachment means are attached to said second end
of said support strap to said waistband of the undergarment having
an expandable pouch for supporting said external urinary
catheter;
wherein said band further comprises a first end portion and a
second end portion and an adjustable fastening means for connecting
said first end portion to said second end portion and said second
end portion determining the tightness of said band around said
proximal end of said external urinary catheter and the penis of the
wearer, and wherein said band further comprises a plurality of
indicating marks for indicating the degree of overlapping between
said first end portion and said second end portion and therefore
the tightness of said band around said proximal end of said
external urinary catheter and the penis of the wearer.
8. The combination of claim 7, wherein said adjustable fastening
means for connecting said first end portion to said second end
portion in an overlapping manner comprises a hook and loop
fastener.
9. The combination of claim 7, wherein said band is made of an
elastic material.
10. The combination of claim 7, wherein said band is made of an
elastic material and wherein said adjustable fastening means for
connecting said first end portion to said second end portion in an
overlapping manner comprises a hook and loop fastener.
11. A combination of a device for retaining an external urinary
catheter onto a penis of a wearer, said external urinary catheter
having a proximal end for encircling the penis of the wearer and a
distal end having a urine collecting compartment and an
undergarment having a waistband, said combination consisting
essentially of:
a band for encircling said proximal end of said external urinary
catheter;
a single support strap having a first end and a second end, said
first end of said single support strap being permanently attached
to said band, said second end of said single support strap having
at least one detachable attachment means, and;
an undergarment having a waistband to be worn about the wearer and
having a pouch means for supporting said urine collecting
compartment of said external urinary catheter, said undergarment
having at least one corresponding detachable attachment means;
whereby said external urinary catheter is retained on the penis of
the wearer by encircling said proximal end of said external urinary
catheter with said band and attaching said at least one detachable
attachment means of said single support strap to said at least one
corresponding detachable attachment means of said undergarment.
12. The combination of claim 11, wherein said band comprises a
first end portion and a second end portion of an adjustable
fastening means for connecting said first end portion to said
second end portion in an overlapping manner, the degree of
overlapping between said first end portion and said second end
portion determining the tightness of said band around said proximal
end of said external urinary catheter and the penis of the wearer.
Description
BACKGROUND--FIELD OF INVENTION
The present invention relates to male urinary incontinence
catheters, in particular to a more dependable means for retaining a
catheter on the penis of a wearer without the use of adhesives.
BACKGROUND--FIELD OF INVENTION
Disclosure Document No. 385874 (dated Dec. 4, 1995), U.S. Pat. No.
5,009,649 (dated Apr. 23, 1991, issued to Victor Goulter and
Barbara Goulter), U.S. Pat. No. 5,380,312 (dated Jan. 10, 1995,
issued to Victor Goulter), and patent application Ser. No.
08/545,403 (filed Oct. 19, 1995), are incorporated by reference as
part of the specification of this invention.
The first clinical trials, at the Shepherd Center of Atlanta, Ga.,
proved the safety, comfort and utility of the one piece Goulter
Condom Catheter device, while defining its single weakness. The
research team concluded that this catheter was superior to the
control device in that it produced less incidence of skin breakdown
and was easier to apply and use. It was also concluded that better
adherence of the device should allow this product to outperform the
control in many other areas as well.
G. D. Johnson in U.S. Pat. No. 4,971,071, dated Nov. 20, 1990
discloses an electrically conductive condom having a permanently
attached retaining strap for securing about the person. The problem
with this method is that it cannot be detached from the condom
itself when quickly removing and refitting a new condom is
required, and also requires the user to undress to reattach another
condom.
P. E. Hogin in U.S. Pat. No. 4,354,494, dated Oct. 19, 1982teaches
an integrally formed strap for retaining a condom in place by
stretching it around the user's scrotum. The problem with this
method are many: firstly, the increasing weight of accumulating
urine in a one-piece urinary incontinence catheter using this
method would exert a pull on the scrotum, and quickly become
unbearably uncomfortable; second, a thin strap as shown in the
patent drawing would cut into the scrotum and add to the discomfort
of the user, especially one who needs to wear it continuously;
thirdly, this device was only intended for brief use, during coitus
for contraceptive purposes.
The Applicants have been diligent, consistent and determined in
seeking ways and means to prevent a catheter, especially their own
of the above-mentioned patents issued and applied for, from
slipping off the user.
In the past, the Applicants used such means as making the sheath
snug-fitting, then increasing tension by using one or more elastic
VELCRO bands around the sheath portion; also, having a series of
fine circular grooves and raised relief ribs incised into the inner
surface of the sheath portion of the catheter to improve grip;
also, of attaching metal rings to the graspable rim of the sheath
for hooking onto a harness or garment to be worn by the user.
All of the above means have been relatively successful in reducing
the tendency of the catheter to slip, but none has been entirely
reliable. The tendency to slip has remained somewhat dependent on
such factors of the shape of the individual's penis; i.e., if the
penis tapers toward the glans, the catheter is more likely to slip
than if the glans is larger in diameter than the shaft. Slipping
has also been affected by how tightly the VELCRO band has been
adjusted to hold the device on the penis, creating a dilemma for
some users, especially those with spinal injuries; bind the band
too loosely and the catheter might slip; bind it too tightly and it
might interfere with circulation.
Several other types of roll-on external catheters, such as those
used with prior-art leg bags, make use of adhesives to hold the
sheath in place. Adhesives, however, have several drawbacks. They
not only fail to guarantee that the sheath will remain in place,
but they often cause pain and sometimes injury while being removed.
As a consequence, they are extremely unpopular with users.
Condom catheter slippage continues to be a major concern among
nursing and care-giving staff, especially those attending the
elderly, the spinal-injured and others likely to suffer male
urinary incontinence. It is equally a worry to the otherwise
able-bodied incontinent, who desire to continue normal activities
and work.
Another problem applies to the use of elastic VELCRO (hook and
loop) bands. These are fitted and adjusted by users and care-givers
in a trial-and-error method to establish the proper amount of
tension needed to hold the sheath comfortably yet firmly in place.
Once the band has been removed however, the position is lost and
must again be sought through trial and error next time it is
applied.
OBJECTS AND ADVANTAGES
Accordingly, one object and advantage of the present invention is
to provide a more positive means to prevent the catheter from
slipping off the penis. Another object and advantage is to provide
a means which can be fitted and/or removed easily and quickly.
Another object and advantage is to provide a means which holds
securely regardless of the shape of the penis.
Still another object and advantage is to provide a means which is
simple and inexpensive to make. Another object and advantage is to
provide a means that can be applied to very short, long, thick,
thin, or retracted penises, regardless of shape or size. A still
further object and advantage is to provide a means to retain
catheters used by incapacitated and spinal injured patients and
which cannot be readily pulled off by the senile or demented.
A further object and advantage is to provide a VELCRO hook and loop
band that can be readily adjusted to a previously established and
desired tension, without the need for repeated guesswork.
BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 is a perspective view a penis fitted with a condom catheter
of U.S. Pat. No. 5,380,312 which has been incorporated by reference
and retained thereon with prior-art elastic VELCRO band.
FIG. 2 is a perspective view of a first embodiment of the present
invention showing a combination of a support strap and an improved
elastic VELCRO band, having a plurality of indicating marks
thereon.
FIG. 3 is a perspective view of the support strap and VELCRO band
combination of FIG. 2 attached to a penis.
FIG. 4 is an enlarged sectional view taken along line 4--4 of FIG.
3, illustrating snap buttons fitted to the support strap and
undergarment's waistband.
FIG. 5 is a perspective view of a second embodiment, comprising a
retainer having a circular groove, which is attached to a garment
to be worn by a user.
FIG. 6 is a perspective detailed view of a grooved retainer for
attaching to a garment.
FIG. 7 is a perspective view of an improved applicator ring used in
conjunction with a grooved retainer.
FIG. 8 is a perspective view of a catheter ready to be stretched
onto an applicator ring.
FIG. 9 is a perspective view of the catheter of FIG. 6 stretched
around and over the end of an applicator ring.
FIG. 10 is a perspective view of a garment including the grooved
retainer encircling a penis, ready to receive a catheter with the
use of an applicator ring.
FIG. 11 is a perspective view of the catheter shown in FIG. 10,
fitted as far as it will go onto a penis and in a position ready
for dislodging graspable ring of the catheter into the grooved
retainer on the undergarment.
FIG. 12 is a perspective view of the catheter of FIG. 11, showing
applicator ring removed entirely, and graspable ring securely
dislodged off the applicator and into the circular groove of the
retainer.
As shown, a VELCRO band having tension marks thereon may be fitted
around the sheath portion of the catheter to enforce a seal.
DETAILED DESCRIPTION--FIGS 1-4
FIG. 1 shows a one-piece male urinary incontinence condom 10 of
U.S. Pat. No. 5,380,312 which has been incorporated by reference,
fitted onto a flaccid penis, 12. In previous embodiments, it is
usually retained thereon by a prior-art elastic VELCRO band 14. The
weight of voided urine which collects in the collection compartment
16 of condom 10 is supported by the extended pouch 17 of a modified
undergarment shown in FIG. 3 in this application and also in FIG. 4
of our U.S. Pat. No. 5,009,649. However, since this embodiment was
not always successful in keeping the Goulter condom catheter on
tapering penises, the purpose of the present invention is hold the
device in place more securely.
The present invention achieves this by the use of a support strap
18 (best seen in FIG. 2), which is combined with VELCRO band 20,
preferably by sewing or otherwise securing strap 18 and band 20
together, as shown at 22 (FIG. 2). Support strap 18 has sufficient
length to be attached to the waistband 30 (FIG. 3) of a modified
undergarment by any suitable means, such as snaps or press studs or
the like.
VELCRO band 20 (FIGS. 2 and 3) also shows a plurality of six
indicating marks 21, permanently imprinted or otherwise made on
loop section 23. Marks 21 are spaced about 5 mm (0.187") apart. A
single cooperating mark 25 is made on hook section 27, such that
when the user is fitting VELCRO band 20, mark 25 will align with,
or near, one of the six marks 21, thus providing a visual read-out
of where hook section mark corresponds relative to one of the loop
section marks. Once the user has decided on the degree of tension
and pressure most comfortable for himself, he can quickly achieve
exactly the same fit each time he reuses the band in the future. If
he feels it necessary to change the adjustment, he can note the
change and use that as a future guide. The proper setting can be
recorded by a care-giver as well, and also explained or directed to
other care-givers; this would be especially useful in a nursing
home setting, above all where incapacitated, helpless, senile or
spinal-injured patients are treated.
It is recommended that our patented pouch-enlarged undergarment
shown in FIG. 3 of this application and in FIG. 4 of our issued
U.S. Pat. No. 5,009,649 be used with the condom catheter, and that
snaps or similar adjustable anchoring means be attached to the
waistband of said garment, to secure the support strap. The use of
such a garment supports the device both from below, by pouch 17,
and above, by support strap 18.
In order to conveniently and securely attach support strap 18 to
modified undergarment's waistband 30, support strap 18 (FIGS. 2-4)
is fitted with multiple male-part snaps, or press studs, 24, while
one or two female-part snaps or press studs 24' are sewn to
waistband 30 of the undergarment, such that while VELCRO band 20 is
attached to a catheter at its lower end, the upper end is anchored
to waistband 30 by the snaps, thereby positively securing condom 10
to penis 12 and preventing it from slipping off the penis.
It will also be realized that retention will no longer depend so
heavily on pressure exerted by the VELCRO band. The band need only
be sufficiently snug to form a seal and so that it will not slip
back over the graspable ring 26, which is made integrally with the
catheter during manufacture.
FIG. 4 shows a sectional view taken along broken line 4--4 of FIG.
3, showing portion of the user's body 32, portion of undergarment
and its waistband 30 fitted with female-part snaps 25, and portion
of support strap 18 fitted with male-part snaps 24'. Multiple
fitting of male part snaps along the upper end of strap 18 allows
for the adjustment of the length of strap 18 according to the
height and body build of the user, so as to obtain the best length
of strap in order to support catheter 10.
Alternatively, snaps can be replaced with buttons and button holes,
hooks and eyes, VELCRO hook-and-loop portions; the support strap
can even be secured to the waistband with a safety pin.
Support strap 18 can be made of any suitable non-elastic flexible
fabric; it can also be made entirely or in part of elastomeric
material, such as elastic bands or even latex strips. Testing has
shown that fabric, elastic and combination support straps achieve
similarly satisfactory results.
Support strap can also be attached to an elastic VELCRO band around
a penis by a tab of hook-side VELCRO which can be sewn to the lower
end of the strap. This method, however, carries the remote danger
that the strap and the band may become separated; therefore, a
positive attachment of strap and band (i.e., by sewing) is
preferred.
In use, the weight of urine, as it accumulates in collecting
compartment 16 of catheter 10, is supported both from beneath, by
the undergarment pouch, and from above, by the tethered support
strap and waistband. Together, they promote retention of the
catheter irrespective of the penis' shape. Rather than pulling down
on the wearer's penis, like most condom catheters currently
available do, the Goulter condom catheter is so well supported that
users have no sensation of wearing the device until the bulk of
voided urine increases sufficiently to act as a reminder to drain
the compartment. Draining, in turn, can be done by simply unzipping
the trouser fly, pulling the end of the device out through the fly
of the undergarment, and opening the release valve, making it
possible for the wearer to use any convenient toilet or urinal.
SECOND EMBODIMENT--FIGS 5-12
FIG. 5 shows a simple garment comprising a frontal section 36
incorporating a circular grooved retainer 38, an elastic waistband
40 at the top, and two leg straps 42 leading from the bottom of
section 36 to the waistband at the side. Circular annular grooved
retainer 38 (FIG. 6), hereafter called `retainer,` can be made in
two sizes, one larger in inner diameter than the thickness of most
penises at the base and another of smaller diameter. Such retainers
of whichever size, can be made of any suitable material, such as
plastic, polyurethane, laminated wood, metal, fiber-glass, or any
other skin-compatible suitable substance. The retainer has an
outward facing circular groove 44, which protrudes forward of a
mounting flange 46. Flange 46 is provided with multiple holes 48
for sewing flange 46 to frontal section 36 (FIG. 5). Frontal
section 36 is preferably made of soft thick fabric, which acts as a
protecting buffer between retainer 38 and the user's body.
Preferably, waistband 40 is made of wide elastic material in
various waist sizes to suit individual users. It can also be made
adjustable in size by known methods for individual users. Leg
straps 42 can be made either of fabric or elastic material.
FIG. 7 shows an improved applicator ring 50, which is tapered, thus
providing a large end 52 and a small end 53. Individual ends can be
used effectively when fitting large and small size catheters onto
penises and retainers.
FIG. 8 shows a catheter being fitted onto large size end 52 of an
applicator ring, while FIG. 9 shows the graspable ring 26 of the
catheter securely placed over large end 52, ready for fitting the
catheter onto penis 54 as shown in FIG. 10.
FIG. 11 shows the catheter fitted as far as it will go onto penis
54 and large end 52 of applicator against front section 36 of the
garment. In this position, graspable ring 26 is rolled off the end
of the applicator ring and into groove 44 of the retainer in the
direction of arrows "K".
FIG. 12 shows the catheter fitted onto penis 54, its graspable ring
26 securely locked and seated in annular groove 44. In this
position the catheter is anchored securely to the garment and
therefore cannot slip off the penis. The pressure applied between
the sheath portion of the catheter and the penile shaft by the
improved VELCRO band can be reapplied in the exact position to
prevents the leakage of urine. It will be seen that mark 25 on the
hook portion (FIG. 12) is aligned with the third mark 21 on the
loop portion 27 of the band. Even too-large a catheter can be
sealed against leakage by adding an elastic VELCRO band 56 attached
around the sheath portion as shown in FIG. 12, tightened just
sufficiently to effect a liquid tight seal.
Modified undergarment with enlarged pouch shown in FIG. 3 of this
application and more clearly in our issued U.S. Pat. No. 5,009,649,
herein incorporated by reference, is used in conjunction with the
garment shown in FIG. 12 of this embodiment and is required for
providing adequate support for the accumulation of urine collected
in the condom catheter. This arrangement is suitable both for
able-bodied users and bedridden patients.
SUMMARY, RAMIFICATIONS, AND SCOPE
Thus, the reader will see that the present invention has many
advantages over prior art male incontinence devices. The
non-disabled user enjoys freedom to engage in a normal life-style,
including social and athletic activities such as working, swimming,
aerobics, driving, running, skiing, dancing, or riding horses or
motorcycles, without having to worry about the catheter coming off
unexpectedly. He can dress in standard street clothing, knowing
that his incontinence is imperceptible to all, even when he stands
side by side with other men at a urinal. Patients and staff in
hospitals can rest assured that the catheter will not come off
until and unless purposely released from the retaining devices.
Care-givers and users also will feel increased confidence in the
use of elastic VELCRO straps due to the plurality of indicating
marks relating to tightness of the band.
While the above description contains many specificities, the reader
should not construe these as limitations on the scope of the
invention, but merely as exemplifications of preferred embodiments
thereof. Those skilled in the art will envision that many other
possible variations are within its scope. For example, other forms
of garments can be designed to attach the support strap; an
anchoring patch can be adhesively attached to the bare skin of a
user for attaching a support strap; or a waistband alone can be
used to attach the support strap onto.
Accordingly, the reader is requested to determine the scope of the
invention by the appended claims and their legal equivalents, and
not by the examples which have been given.
* * * * *